Donepezil 10 mg lot recalled after concern it may contain oversized tablets

Pro Doc Limitée has recalled a lot of Donepezil 10 mg tablets because it may contain pills that are too large. Health Canada released a public advisory on the recall, saying that the oversized tablets contain up to three times the intended dose. The lot has the DIN 02416425 and lot number 645766. Health Canada asks pharmacists to check bottles of Donepezil 10 mg tablets before they dispense them and report unusual packaging to Health Canada and the company. Doctors prescribe Donepezil for Alzheimer’s disease. The maximum daily dose is 10 mg/day, and the oversized pills may be up to 30 mg. That could result in an increase in side effects, such as nausea, diarrhea, vomiting, fatigue, loss of appetite, insomnia and muscle cramps. In clinical trials, adverse events have been found to be more frequent in older patients and female ones. It can also cause cardiovascular adverse events, including slow heartbeat, heart block and loss of consciousness. Read: Health Canada introduces Canadian Product Safety Pledge Increased doses may also cause symptoms of neuroleptic malignant syndrome, like high fever, muscle stiffness, irregular blood pressure, pulse or heartbeats, confusion, agitation or coma—all of which require immediate medical attention. It may also result in a cholinergic crisis, which results in severe nausea, vomiting, salivation, sweating, slow heartbeats, low blood pressure, reduced breathing, loss of consciousness and convulsions. Increasing muscle weakness is also possible, Health Canada said, and if respiratory muscles are involved, it may be fatal. Health Canada advised patients and caregivers to check their bottles of Donepezil 10 mg tablets for larger pills and return them to their pharmacy if they found them or were unsure if they had them. They should also watch for side effects from Donepezil and get medical attention if necessary. Read: Barefoot workers and cracked floors were found at a factory that made recalled eyedrops, FDA says

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